According to the Regulations on the Supervision and Administration of Medical Devices, the Rules for the Classification of Medical Devices, the Classification Catalogue of Medical Devices, the Measures for the Registration and Administration of Medical Device Registration, and the Measures for the Registration and Administration of in Vitro Diagnostic Reagents, the applicant shall submit the registration application data to the drug regulatory departments of the provinces, autonomous regions and municipalities directly under the Central Government. For the registration of Class III medical device products, the applicant shall submit the registration application data to the National Bureau.

1. Those who produce medical devices without licenses shall have their illegal gains, related production materials, tools and equipment confiscated. Whoever illegally produces a product with a value of more than 10,000 yuan shall concurrently be fined not less than 10 times but not more than 20 times the value of the product; If the circumstances are serious, the application for medical device license submitted by the relevant responsible person and enterprise shall not be accepted within 5 years;

2, provide false information or take other deceptive means to obtain medical device registration certificate, production license, revoke the license, and impose a fine of more than 50,000 yuan and less than 100,000 yuan, within 5 years do not accept the medical device license application made by the relevant responsible person and unit.

3, forging, altering, trading, leasing, lending medical device license, confiscate or revoke the license, confiscate the illegal income; If the illegal income is not less than 10,000 yuan, he shall be fined not less than three times but not more than five times the illegal income; If it constitutes an act violating the administration of public security, the public security organ shall punish it for the administration of public security according to law.

1. Copy of business license

2, legal representative, responsible person ID copy

3, production, quality and technical person in charge of identity, education, title certificate copy

4, production management, quality inspection positions of employees education, title list

5, production site certification documents, there are special production environment requirements should also submit facilities, environmental certification documents

6, production site plan (workshop, laboratory, warehouse)

7, the main raw materials, material list, production process, equipment list

8, product registration test sample

9. Clinical trial data (* The above is for reference only, and the details are determined after discussion between the two parties in the actual case)

Registration certificate is valid for 5 years, application for renewal 6 months before expiration